FDA 510(k)

EON 過濾系統式可攜式RO水淨化設備

K 號：K200670 · 2020-04-16

決定日期2020-04-16

產品代碼FIP

諮詢委員會GU

決定相當於

器材摘要

EON Portable RO Water Purification System is the device name listed in this FDA 510(k) record. The listed applicant is Mar Cor Purification, Inc.. It received FDA 510(k) clearance on 2020-04-16 under 510(k) number K200670. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EON Portable RO Water Purification System?

EON Portable RO Water Purification System is a medical device that received FDA 510(k) clearance on 2020-04-16. The listed applicant is Mar Cor Purification, Inc.. The 510(k) number is K200670.

When did EON Portable RO Water Purification System receive FDA 510(k) clearance?

EON Portable RO Water Purification System received FDA 510(k) clearance on 2020-04-16, under 510(k) number K200670.

Who is the listed applicant for EON Portable RO Water Purification System?

The FDA 510(k) record lists Mar Cor Purification, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EON Portable RO Water Purification System?

The FDA product code for EON Portable RO Water Purification System is FIP.

其他以 Mar Cor Purification, Inc. 為申請人之記錄

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K192398米倫尼姆HX

相關器械（代碼：FIP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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